Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
 

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

Fostering the Development of Interdisciplinary Team Science for the Study of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) (R24)

Activity Code

R24 Resource-Related Research Projects

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DK-10-016

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.847   

FOA Purpose

The present Funding Opportunity Announcement (FOA) supports the development of collaborative, inter-disciplinary research teams using innovative approaches to answer a single critically important research question relevant to our understanding, prevention, diagnosis or treatment of the urologic pelvic pain syndrome traditionally referred to as interstitial cystitis/painful bladder syndrome (IC/PBS). Collectively, the team effort should represent a greater contribution to program goals than would occur if each team member worked individually. Critical research questions are expected to reflect new approaches for IC/PBS research.  Research teams should be comprised of investigators with the necessary expertise to answer the critical research question and are likely to be drawn from diverse but complementary expertise from fields of clinical, basic, and/or translational science; inclusion of traditional clinical urology expertise is encouraged. It is expected that the team members will have independent research support and are expected to be established, independent investigators who bring key scientific strengths to the program. It is anticipated that assembled research teams supported through this program will be positioned to seek future awards that will enhance our understanding urologic pelvic pain and associated conditions.

Key Dates
Posted Date
Letter of Intent Due Date

March 16, 2011

Application Due Date(s)

April 13, 2011

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

June/July, 2011

Advisory Council Review

October, 2011

Earliest Start Date(s)

December, 2011

Expiration Date

April 14, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The urologic chronic pelvic pain syndrome (UCPPS) traditionally referred to as interstitial cystitis/painful bladder syndrome (IC/PBS) is defined by the hallmark symptom of chronic pain in the pelvic region or urogenital floor. The presence of various lower urinary tract symptoms (LUTS), such as urgency and frequency, are also commonly found in IC/PBS patients. The burden of IC/PBS is enormous and patients can suffer significant morbidity throughout their lives.  Estimates of the prevalence of IC/PBS vary, but recent reports have suggested approximately 3-6% of American women over the age of 18 exhibit symptom criteria.  This translates into potentially eight million women. IC/PBS is believed to occur in men as well, though the gender-based differences between female and male urologic pelvic pain remain to be fully described.  While the bladder has been traditionally viewed as the source of IC/PBS symptoms, including pain, no organ-specific pathology has been conclusively identified in the majority of patients. Moreover, to date, no underlying etiology has been revealed for IC/PBS. IC/PBS diagnosis and disease severity remain primarily described in terms of symptom profiles rather than identifiable and measurable molecular, cellular, or anatomical criteria.  Currently there are no generally effective treatments for IC/PBS patients or strategies for preventing disease development. 

The lack of key insights for UCPPS, including IC/PBS, after many years of basic science and clinical studies, has suggested to the NIDDK that new research approaches are needed.  In recent NIDDK sponsored efforts, such as the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network (http://www.mappnetwork.org/), collaborative, multidisciplinary studies emphasizing new and novel approaches to characterize UCPPS have been stressed. In addition, the NIDDK is emphasizing the view that UCPPS is a systemic condition and should not be viewed simply as organ-based disease.  Because of overlapping symptom profiles the MAPP Network has included both IC/PBS and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) within the broad term UCPPS and is interested in the relationships between these disorders and with other urologic and non-urologic disorders seen in UCPPS patients.

Despite the ongoing work of the MAPP Research Network and other relevant efforts, the NIDDK recognizes that not all important questions for UCPPS, and more specifically for IC/PBS, are being addressed and some new or important traditional research areas may be understudied by current efforts.  In response to these needs, the present research opportunity is designed to promote the development of research teams with diverse expertise for addressing a critical research question focused on IC/PBS. Studies that address key questions that are currently not being fully exploited by the research community are encouraged.

Research Objectives

The complexity of biomedical science often requires the input and expertise of multiple collaborating investigators working as an investigative team.   Currently support for collaborative research may take the form of a large R01 with a Principal Investigator (PI) and one or more key personnel and/or collaborators; a multi-PI R01 where credit and responsibility for a project are shared; a Program Project grant (P01) with three or more individual and independent projects, with cores, centered on a common theme; or a Center supporting a focused set of activities.  While the R01, P01 and Centers mechanisms can foster certain kinds of collaborations, their structures cannot always readily accommodate many types of collaborative research.  R24s are more flexible than the P01 in that they do not require individual projects or cores and can include discovery or hypothesis-generating research and the development of unique resources or technologies. Collectively, the team should bring together the necessary expertise to answer a specific critical question and result in a greater contribution to program goals than would occur if each team member worked individually.  R24s can support basic, translational, and clinical sciences.  It is expected that R24s will have translational and/or clinical relevance.  The present funding program utilizes this R24 mechanism to foster the development of collaborative research teams to conduct research studies addressing a single key question for understanding the pathophysiology of the urologic pelvic pain syndrome IC/PBS.

Research and Research Teams

Proposed basic, translational, or clinical research studies must address a single critical research question of high scientific impact relevant to furthering our understanding of the pathophysiology of the urologic pelvic pain syndrome, traditionally referred to as IC/PBS.  Proposed research must, if successful, make a major impact on our understanding of the presentations, diagnosis, etiologies, subgroups, and/or natural history of IC/PBS.  In addition, findings must have the potential to inform on the development of improved treatments or for prevention strategies. Studies can include discovery or hypothesis-generating research and the development of unique resources or technologies.  No individual sub-projects or cores are permitted.

A major feature of the present funding opportunity is to foster highly collaborative, inter-disciplinary teams with the necessary expertise to address the posed critical research question. Such teams will likely be comprised of urology research expertise, as well as investigators possessing diverse but complementary expertise from fields of clinical, basic, and/or translational science.  Teams are encouraged to include clinical urology research expertise to ensure that the question addressed in the research study is clinically relevant and has the potential to impact patient care.  There are no limitations on the research backgrounds of members of the assembled team and groups rich in the necessary diversity of research expertise are encouraged to pursue a single critical research question using novel approaches. The unique contributions of all personnel must be justified in the body of the application.  Teams consisting of individuals with prior collaboration are allowed. However, prior collaboration is not required and new interactions established for the purposes of applying to this funding opportunity are highly encouraged.

The proposed interdisciplinary research team is to be lead by an established investigator who will devote significant effort to the project (at least  1.2 person months for the one year R24 funding period).  The research team should be comprised of this team leader and additional established, independent investigators with strong publication records and independent research support who will bring critical scientific expertise to the program.  The assembled team will collaboratively develop a synergistic approach to investigating a single critically important research question relevant to IC/PBS.

It is anticipated that assembled research teams supported through this  award will be positioned to seek future awards to expand projects funded in this effort or to initiate new research studies relevant to the study of IC/PBS and associated conditions. This may be accomplished through a variety of award mechanisms including the NIDDK Collaborative Interdisciplinary Research Program in Diabetes, Endocrinology and Metabolic Diseases solicitation (see PAR-08-182 and NIH Guide Notice NOT-DK-10-008, which expands PAR-08-182 to include a broader list of NIDDK specific topics including urologic chronic pelvic pain syndromes).

Support awarded through the present funding opportunity can be used in a variety of ways, with the ultimate goal of establishing a well-integrated, outstanding, and highly functional team poised to address clinically important questions relevant to IC/PBS.  To enhance team research activities, funds may be requested to support sharing of unique reagents, expertise and equipment; shared students or research staff; travel to enhance collaboration; as well as other justified activities related to the formation and functioning of the investigative team and for conducting the research project. Support is not meant to provide substantial salary support for team members or to purchase large pieces of equipment. All team members are expected to function as key personnel.  Funding decisions will be based on criteria for programmatic relevance and scientific quality that are more selective compared to regular R01 research projects.

Anticipated research team activities during the 12 month funding period would include planning and initiating research efforts and the generation of preliminary data for incorporation into a future grant application to expand projects funded in this effort or to initiate new research studies relevant to the study of IC/PBS and associated conditions.

Scientific Priorities

Studies are expected to address questions of key clinical relevance that, if successful, may contribute to the diagnosis, treatment, or prevention of IC/PBS.  All studies are expected to focus on assessment of IC/PBS using studies in humans, with human samples, or relevant in vivo, ex vivo, and in vitro methods.  Projects that help move IC/PBS from a syndrome to a better defined disease are encouraged.  Studies exclusively employing utilizing animal models are not within the scope of this funding opportunity. However, research that translates new clinical findings into basic studies in model organisms (bedside to bench), or translates existing findings derived from animal models to testing in patients (bench to bedside) are responsive.  Any animal model systems proposed must be highly justified as useful for understanding IC/PBS.  Studies may assess the potential pathological relationships between IC/PBS and co-morbid disorders, provided understanding the pathology of IC/PBS is the primary emphasis. For the purposes of this effort, relevant co-morbid conditions include fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, vulvodynia, chronic prostatitis/chronic pelvic pain syndrome, temporomandibular joint disorder, and migraine headache.  Research projects investigating other urologic disorders involving lower urinary tract symptoms (LUTS) and/or normal urologic function are permitted if a convincing justification can be made in the application that these efforts are of direct relevance to improving our understanding of IC/PBS and how these efforts will lead to improved diagnosis or treatment of IC/PBS.  The applicant is responsible for explaining this direct relevance if such a study is proposed.  Relevant urologic disorders include but are not limited to urinary incontinence, benign prostatic hyperplasia/LUTS, and overactive bladder.

Studies that are deemed as substantially overlapping with the MAPP Network or other previous or current research efforts will not be supported.  Applicants are encouraged to review the MAPP Network's website (http://www.mappnetwork.org/) to assess overlap with the network's efforts and also to contact appropriate NIDDK Program Staff to discuss potential overlap of proposed studies with MAPP Network scientific studies or other efforts currently supported by the NIDDK.

Specific research priorities include, but are not limited, to the below:

How might new or enhanced minimally invasive methods be employed to better assess bladder and lower urinary tract function in normal versus disease states?

How might novel approaches for structural and/or functional imaging of the pelvis, urogenital floor, and abdomen be used to identify anatomical features associated with symptom profiles?

What is the biological basis of symptom flare and remission, as well as associated physiology and risk factors?

What is the relationship between acute, chronic, or latent infection and the predisposition to development of IC/PBS symptoms?

What is the contribution of pain pathways or alterations in neuronal factors to changes in pain profiles and perceptions observed in patients?

Is there a contribution of gender specific characteristics and pathophysiology to IC/PBS?

What are the pathological relationships between IC/PBS and other urologic disorders characterized by the presence of LUTS and how does this inform directly on our understanding of IC/PBS?

How does the physiology of healthy urologic and non-urologic systems and processes compare and contrast to that seen in urologic and non-urologic systems in IC/PBS patients or patient-derived biological samples?

What are the underlying physiological and pathological mechanisms that link IC/PBS with co-morbid disorders including fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, vulvodynia, chronic prostatitis/chronic pelvic pain syndrome, temporomandibular joint disorder, and/or migraine headache?

How may clinical findings be further assessed through basic research studies, including in model organisms?

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIDDK will commit approximately $600,000 and the ORWH will commit approximately $100,000 in order to support approximately two research awards in FY2011.

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are limited to $350,000 Total Costs (i.e., Direct Costs plus Indirect Costs) and need to reflect actual needs of proposed project

Support is not meant to provide substantial salary support for team members or to purchase large pieces of equipment.

Applications may request up to $75,000 in Direct Costs per Principal Investigator to yield a final proposed budget not to exceed the funding cap of $350,000 Total Costs. 

Award Project Period

 The maximum funding period is one year.   

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign (non-U.S.) components of U.S. Organizations are  allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.     

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Francisco Calvo, PhD
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
E-mail: fc15y@nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Francisco Calvo, PhD
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
E-mail: fc15y@nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed,

Research Plan

All instructions in the PHS398 Application Guide must be followed.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, .

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide,

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants should use the appropriate sections from the PHS 398 forms. All applications must contain:

In addition, each application should contain:  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

If successful will the proposed study provide new and important insights into the pathophysiology, etiology, and/or natural history of IC/PBS, potentially also including new insights into the relationship between IC/PBS and associated urologic or non-urologic disorders? If successful will the proposed study generate findings that have the potential to improve on diagnosis, treatment, and/or prevention of IC/PBS?   

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 

Does the designated leader of the assembled team possess the appropriate expertise and qualifications to allow him/her to successfully lead the assembled research group? Do the team leader and assembled team members possess current, independent research, strong publication records, and bring critical expertise to the program? Is sufficiently diverse, interdisciplinary research expertise represented in the team to successfully address the proposed research question? Do principal investigators comprising the research team provide evidence of significant, independent research support?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

 Are the proposed scientific approaches considered innovative for the field of IC/PBS and have the potential to yield new and novel findings that will provide significant advances?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? 

Does the proposed scientific approach address a single research question critical for advancing our understanding of the pathophysiology, natural history, patient phenotype, diagnosis, treatment, and/or prevention of IC/PBS?Is the scientific approach sufficiently interdisciplinary to adequately address the research question? If the approach proposes the use of animal model systems, are these systems sufficiently justified as useful for understanding IC/PBS? Does the scientific approach involve substantial involvement and collaboration between all members of the assembled team? If a study proposes to assess additional urologic disorders involving LUTS does the proposal contain a strong justification for how this effort will directly improve our understanding of IC/PBS and potentially lead to improved diagnosis or treatment of IC/PBS?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

For the review of applications responding to the current FOA, the additional review criteria will be used:

What is the potential of this seeding project to lead to a future, successful application to the NIDDK or other funding agency? 

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research..   

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

Applications will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC) . The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. . More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Chris Mullins, Ph.D.
Director of Basic Cell Biology Programs
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 637
Bethesda, MD 20892-5458
Telephone: 301-451-4902
Email:mullinsc@mail.nih.gov

Peer Review Contact(s)

Francisco Calvo, PhD
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
E-mail: fc15y@nih.gov

Financial/Grants Management Contact(s)

Mr. William Etti
Grants Management Branch
Division of Extramural Activities,
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 722, MSC 5456
Bethesda, MD 20892-5456
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-7451
FAX: (301) 594-9523
E-mail: ettiw@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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